Supernus Resubmits New Drug Application for Parkinson's Treatment Device

By Mark R. Long

Supernus Pharmaceuticals resubmitted its new-drug application for a device to treat patients with Parkinson's disease to the Food and Drug Administration.

The Rockville, Md. biopharmaceutical company said on Thursday it believes it has addressed the questions in an April letter from the FDA about the review of its SPN-830 apomorphine-infusion device to treat "off" episodes in Parkinson's patients. The company, which focuses on central-nervous-system diseases, said the agency indicated its review was complete, but two areas either required additional review or more information from the company. No clinical or safety issues were identified at that time.

Off periods can occur in people with Parkinson's disease when there is a spike in symptoms in between treatment doses. The SPN-830 device is specifically meant to continuously treat motor fluctuations associated with these episodes.

Shares of Supernus fell on news of the FDA's letter in April, and the stock was down 4.8% at $28.14 in after-hours trading Thursday.

Write to Mark R. Long at mark.long@wsj.com

(END) Dow Jones Newswires

August 01, 2024 18:07 ET (22:07 GMT)

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